Class 2 Device Recall NelDerm Hydrogel Dressing

• Date Initiated by Firm: February 11, 2020
• Create Date: May 21, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2083-2020
• Recall Event ID: 85343
• Product Classification: Dressing, wound, hydrogel without drug and/or biologic - Product Code NAE
• Product: NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
• Code Information: Lot #90971
• FEI Number: 3015524870
• Recalling Firm/ Manufacturer: Nelson Innovaions, Llc; 18944 W 130th St; Strongsville OH 44136-8427
• Manufacturer Reason for Recall: Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
• FDA Determined Cause: Process control
• Action: Nelson Innovations, LLC contacted customers on 2/11/20 via phone call to state reason for recall, health risk and request return of affected product and provided call tags for pick-up of product.
• Quantity in Commerce: 100 units
• Distribution: CA, NC, PR
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.